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Opioid Dependence: Buprenorphine Prolonged- Release Injection (Buvidal)

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Opioid Dependence: Buprenorphine Prolonged- Release Injection (Buvidal) Evidence review Opioid dependence: buprenorphine prolonged- release injection (Buvidal) Publication date: February 2019 This evidence review sets out the best available evidence on buprenorphine prolonged-release injection (Buvidal) for treating opioid dependence. It should be read in conjunction with the evidence summary, which gives the key messages. Commissioned by Public Health England. Disclaimer The content of this evidence review was up-to-date in February 2019. See summaries of product characteristics (SPCs), British national formulary (BNF) or the Medicines and Healthcare products Regulatory Agency (MHRA) or NICE websites for up-to-date information. Copyright © NICE 2019. All rights reserved. Subject to Notice of rights. ISBN: 978-1-4731-3246-7 Evidence review: Opioid dependence: buprenorphine prolonged-release injection (Buvidal) (February 2019) 2 of 29 Contents Contents ..................................................................................................................... 3 Background ................................................................................................................ 4 Product overview ........................................................................................................ 4 Mode of action ........................................................................................................ 4 Regulatory status .................................................................................................... 4 Dosing information .................................................................................................. 5 Effectiveness .............................................................................................................. 6 Opioid-negative urine samples ............................................................................... 6 Responder rate ....................................................................................................... 7 Study retention........................................................................................................ 7 Opioid craving and withdrawal symptoms ............................................................... 7 Additional buprenorphine doses ............................................................................. 7 Psychosocial counselling ........................................................................................ 8 Safety ......................................................................................................................... 8 Person-related factors ................................................................................................ 9 Evidence strengths and limitations ........................................................................... 10 Resource impact ...................................................................................................... 11 Likely place in therapy .............................................................................................. 12 Development of the evidence review........................................................................ 14 Process ................................................................................................................. 14 Expert advisers and declarations of interest ......................................................... 14 Terms used in this evidence review ......................................................................... 16 Appendices .............................................................................................................. 17 Appendix A: Summary of included study .............................................................. 17 Appendix B: Results tables ................................................................................... 19 Appendix C: Quality assessment of included studies ........................................... 22 Appendix D: Literature search strategy ................................................................. 23 Appendix E: Studies excluded and not-prioritised................................................. 27 Evidence review: Opioid dependence: buprenorphine prolonged-release injection (Buvidal) (February 2019) 3 of 29 Background The UK has relatively high rates of heroin and crack cocaine misusers compared with many other western countries. However, the proportion of these drug misusers in treatment is also very high compared with many other countries. Most adult drug misusers in treatment in the UK report opiates (primarily heroin) as their main problem drugs (UK guidelines on clinical management of drug misuse and dependence, 2017). Methadone and buprenorphine are both effective medicines for maintenance treatment of opioid dependence, particularly when taken within the optimal dose range. The NICE technology appraisal on methadone and buprenorphine for the management of opioid dependence recommends that either of these drugs (as oral formulations), using flexible dosing regimens, are options for maintenance therapy in the management of opioid dependence. Supervised consumption should be available to all people to support induction on to opioid substitution therapy, and provided for a length of time appropriate to their individual needs and risks. Those on supervised consumption will often still have take-home medication on Sundays and some bank holidays (UK guidelines on clinical management of drug misuse and dependence, 2017). Risks of providing take-home medication may include accidental ingestion of opioid substitution medicines by children and others, and risks of diversion. In some settings, such as custodial environments, supervised consumption of opioid substitution therapy is mandatory for the time the person is resident in the secure environment. Product overview Mode of action Buvidal is a prolonged-release injection of buprenorphine used in opioid dependence. Buprenorphine is an opioid partial agonist/antagonist which binds to the mu and kappa opioid receptors in the brain. Its activity in opioid maintenance treatment is attributed to its slowly reversible properties with the mu opioid receptors which, over time, might minimise the need for illicit opioids for people with opioid dependence (summary of product characteristics). Regulatory status Buprenorphine prolonged-release injection (Buvidal) has a marketing authorisation for treating opioid dependence within a framework of medical, social and psychological treatment in adults and young people aged 16 years and over (summary of product characteristics). Evidence review: Opioid dependence: buprenorphine prolonged-release injection (Buvidal) (February 2019) 4 of 29 Dosing information Buprenorphine prolonged-release injection is available as a weekly injection in 8 mg, 16 mg, 24 mg and 32 mg strengths and a monthly injection in 64 mg, 96 mg and 128 mg strengths. A healthcare professional should give buprenorphine prolonged-release injection subcutaneously. It must not be administered intravenously, intramuscularly or intradermally. Take-home use or self-administration should not be allowed. To avoid precipitating symptoms of withdrawal, treatment should be started when there are clear signs of mild to moderate opioid withdrawal. For people using heroin or short-acting opioids, the first dose should be given at least 6 hours after the last use of opioids. For people receiving methadone, the methadone dose should be reduced to a maximum of 30 mg per day before starting treatment, which should begin at least 24 hours after the last methadone dose. People who have not had buprenorphine before should have 4 mg of sublingual buprenorphine with observation for 1 hour, before receiving buprenorphine prolonged- release injection for the first time. This is to confirm that buprenorphine can be tolerated. For people not already receiving buprenorphine, the recommended starting dose is 16 mg of the weekly formulation of buprenorphine prolonged-release injection, with 1 or 2 additional 8- mg doses given at least 1 day apart to reach a target dose of 24 mg or 32 mg during the first week. The recommended dose in the second week is the total dose given during the first week given in a single weekly injection. Monthly injections can be started once a person is stable on weekly injections, preferably after 4 weeks or more. People already receiving sublingual buprenorphine can be switched directly on to weekly or monthly buprenorphine injections, starting the day after the last sublingual dose, according to the dose conversion recommendations provided in the summary of product characteristics. The dose of buprenorphine prolonged-release injection can be increased or decreased, with switching between weekly and monthly preparations according to individual needs and clinical judgement. A maximum of 1 additional 8 mg dose can be given between regular weekly or monthly doses if needed. The maximum dose per week is 32 mg with 1 additional 8 mg dose. For people on monthly injections, the maximum dose is 128 mg per month, with 1 additional 8 mg dose (summary of product characteristics). The prolonged-release characteristics of the injection should be taken into account when treatment is stopped. Sublingual buprenorphine should not be given until 1 week after the last weekly dose or 1 month after the last monthly dose (summary of product characteristics). Evidence review: Opioid dependence: buprenorphine prolonged-release injection (Buvidal) (February 2019) 5 of 29 Effectiveness This evidence review discusses
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